Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan, China.
BMJ Open. 2024 Nov 12;14(11):e090554. doi: 10.1136/bmjopen-2024-090554.
Olfactory dysfunction (OD) is a prevalent nasal affliction that has detrimental effects on the patients' quality of life and safety. Conventional therapeutic strategies have various limitations such as high costs, prolonged treatment durations and adverse side effects. Intranasal insulin is a novel intervention for the management of OD. To date, few systematic reviews have been conducted to evaluate the efficacy of this intervention. This study aims to critically assess the therapeutic efficacy and safety profile of intranasal insulin administration in patients with OD.
A systematic literature search will be performed on several databases, including PubMed, the Cochrane Central Register of Controlled Trials, Embase, SinoMed and China National Knowledge Infrastructure (CNKI), to identify studies investigating the efficacy of intranasal insulin in treating OD. The search will span from database inception to 1 April 2024, including publication in Chinese and English languages. Data will be retrieved from the literature by two independent investigators. Subsequently, the data will be processed using RevMan V.5.3.5. The meta-analysis will be performed in line with the Cochrane Handbook guidelines. The clinical efficacy and safety of intranasal insulin for OD will be appraised based on various outcomes, including overall symptom improvement, the Connecticut Chemosensory Clinical Research Center score, variations in serum glucose levels, body mass index variations and the incidence of adverse events.
This will be a systematic review of available literature; thus, no ethical clearance is required. The results of this study will be shared through journal publication or presented at an academic conference.
According to the guidelines, our systematic review protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO) on 16 May 2024 (registration number CRD42024543438).
嗅觉功能障碍(OD)是一种普遍的鼻腔疾病,会对患者的生活质量和安全造成不利影响。传统的治疗策略存在各种局限性,如成本高、治疗持续时间长和不良反应等。鼻内胰岛素是一种治疗 OD 的新方法。迄今为止,很少有系统评价来评估这种干预措施的疗效。本研究旨在批判性评估鼻内胰岛素给药治疗 OD 患者的疗效和安全性。
将在多个数据库(包括 PubMed、Cochrane 中央对照试验注册中心、Embase、SinoMed 和中国国家知识基础设施(CNKI))中进行系统文献检索,以确定研究鼻内胰岛素治疗 OD 疗效的研究。检索将从数据库建立开始到 2024 年 4 月 1 日进行,包括中文和英文出版物。将由两名独立的研究人员从文献中检索数据。随后,将使用 RevMan V.5.3.5 处理数据。将按照 Cochrane 手册指南进行荟萃分析。将根据各种结局评估鼻内胰岛素治疗 OD 的临床疗效和安全性,包括整体症状改善、康涅狄格化学感觉临床研究中心评分、血清葡萄糖水平变化、体重指数变化和不良事件发生率。
这将是对现有文献的系统评价;因此,不需要伦理审查。本研究的结果将通过期刊发表或在学术会议上报告。
根据指南,我们的系统评价方案于 2024 年 5 月 16 日在国际前瞻性系统评价注册库(PROSPERO)中注册(注册号 CRD42024543438)。